AzTrials
AzTrials

Heart FailureMPP-PMSNCT02832622

MultiPoint Pacing™ Post Market Study

An observational study of Heart Failure, run by Abbott Medical Devices at 128 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
MPP and BiV/MPP
Type of treatment
Medical device
How many people
2,169 participants
Where
128 sitesin 4 countries
Study dates
Jul 2016to 15 Jul 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who are indiciated for a Cardiac Resynchronization Therapy (CRT) device

Who may be able to join

  • Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement
  • Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Who cannot join

  • Are expected to receive a heart transplant during the duration of the study
  • Have an epicardial ventricular lead system (Active or Inactive)
  • Are less than 18 years of age
  • Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
  • Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care

Trial locations and contacts

128 sites in 4 countries.

128 sites in 4 countries

United States110 sites

  • St. Peter's Health Partners Medical Associates, PC

    Albany, New York, 12205

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • Comprehensive Cardiovascular Specialists

    Alhambra, California, 91801

  • Trinity Health-Michigan d/b/a Michigan Heart

    Ann Arbor, Michigan, 48106

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606

  • Emory University Hospital

    Atlanta, Georgia, 30342

  • Aurora Denver Cardiology Associates, P.C.

    Aurora, Colorado, 80012

  • Austin Heart

    Austin, Texas, 78756

  • Integrated Medical Services

    Avondale, Arizona, 85392

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • HeartPlace

    Bedford, Texas, 76021

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35249

  • Cardiac Arrhythmia Services

    Boca Raton, Florida, 33422

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Trinity Medical WNY, PC

    Buffalo, New York, 14215

  • Novant Health Heart and Vascular Research Institute

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Samaritan Heart & Vascular Institute - Cardiology Dept.

    Corvallis, Oregon, 97330

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2150

  • Yoel R. Vivas, MD

    Delray Beach, Florida, 33484

  • VA Medical Center Durham

    Durham, North Carolina, 27705

  • University Hospitals Elyria Medical Center

    Elyria, Ohio, 44035

  • Charlton Memorial Hospital

    Fall River, Massachusetts, 02720

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Virginia Heart - The Cardiovascular Group, P.C.

    Falls Church, Virginia, 22042

  • Pee Dee Cardiology Associates, PA

    Florence, South Carolina, 29506

  • Michigan Electrophysiology Specialists

    Flushing, Michigan, 48433

  • Fort Worth Heart

    Fort Worth, Texas, 76104

  • Cardiovascular Consultants Ltd

    Glendale, Arizona, 85306

  • St. Francis Hospital

    Greenville, South Carolina, 29601

  • Highpoint Regional Hospital

    High Point, North Carolina, 27262

  • Illinois Heart and Vascular - Hinsdale

    Hinsdale, Illinois, 60521

  • Heart Rhythm Solutions

    Hollywood, Florida, 33021

  • Houston Cardiovascular Associates

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • St. Mary's Hospital

    Huntington, West Virginia, 25702

  • Heart Center Research, LLC.

    Huntsville, Alabama, 35801

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Citrus Cardiology Consultants, PA

    Inverness, Florida, 34452

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • Mountain States Medical Group Cardiology

    Johnson City, Tennessee, 37601

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Kearney Regional Medical Center

    Kearney, Nebraska, 68845

  • Cardiovascular Associates, PC (Wellmont Holston Valley M C)

    Kingsport, Tennessee, 37660

  • Naushad Shaik, MD

    Kissimmee, Florida, 34741

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Jorge Diaz, M.D., P.A.

    Lake Mary, Florida, 32746

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • HealthCare Partners Cardiology

    Las Vegas, Nevada, 89169

  • Healient Physician Group

    Leawood, Kansas, 66211

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Lexington Cardiology

    Lexington, South Carolina, 29204

  • BryanLGH Medical Center East

    Lincoln, Nebraska, 68506-1299

  • USC University Hospital

    Los Angeles, California, 90033

  • Jeffrey Goodman

    Los Angeles, California, 90048

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Coliseum Medical Centers

    Macon, Georgia, 31201

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Middletown Cardiovascular Associates

    Middletown, Ohio, 45044

  • MidMichigan Medical Center-Midland

    Midland, Michigan, 48670

  • Gregory C. Sampognaro Interventional Cardiology

    Monroe, Louisiana, 71201

  • Atlantic Health System - Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 08015

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Central Florida Medical Research

    New Smyrna Beach, Florida, 32168

  • Premier Cardiology, Inc

    Newport Beach, California, 92663

  • Cardiology Associates of Fairfield County, PC

    Norwalk, Connecticut, 06851

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • McKay-Dee Heart Services

    Ogden, Utah, 84403

  • Usman R. Siddiqui, MD

    Orlando, Florida, 32837

  • One Health Cardiology

    Owensboro, Kentucky, 42304

  • Desert Heart Rhythm Consultants

    Palm Springs, California, 92262

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Presbyterian Medical Center (PA)

    Philadelphia, Pennsylvania, 19104

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85013

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • John C. Lincoln North Mountain Hospital

    Phoenix, Arizona, 85020

  • Chaparral Medical Group

    Pomona, California, 91767

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Cardiac Rhythm Specialists, Inc.

    Reseda, California, 91335

  • Reid Health

    Richmond, Indiana, 47374

  • Brevard Cardiovascular Research Associates, Inc.

    Rockledge, Florida, 32955

  • Redmond Regional Medical Center

    Rome, Georgia, 30165

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • Cardiology Clinic Of San Antonio Pa

    San Antonio, Texas, 78229

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Arizona Arrhythmia Consultants

    Scottsdale, Arizona, 85251

  • Scranton Cardiovascular Physicians

    Scranton, Pennsylvania, 18510

  • Advanced Cardiovascular Specialists

    Shreveport, Louisiana, 71103

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71130

  • Providence Hospital

    Southfield, Michigan, 48075

  • Kootenai Heart Clinics

    Spokane, Washington, 92204

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • St. Louis Heart and Vascular PC

    St Louis, Missouri, 63136

  • VA Medical Center - Tampa

    Tampa, Florida, 33612

  • COR Healthcare Medical Associates

    Torrance, California, 90505

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Bayview Physicians Services, PC

    Virginia Beach, Virginia, 23454

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Wheaton Franciscan Medical Group - Heart Rhythm Specialists

    Wauwatosa, Wisconsin, 53226

  • Wichita Falls Heart Clinic

    Wichita Falls, Texas, 76301

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania, 19067

Other trials in United States

Japan13 sites

  • Chiba University

    Chiba, 2608677

  • Hirosaki University Hospital

    Hirosaki, Aomori, 0368203

  • Akashi Medical Center

    Hyōgo, Kinki, 6740063

  • St. Marianna University School of Medicine Hospital

    Kanagawa, 2168511

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 8020001

  • Shinshu University Hospital

    Matsumoto, 3908621

  • Niigata University Medical & Dental Hospital

    Niigata, 9518510

  • Sakurabashi Watanabe Hospital

    Osaka, 5300001

  • National Cerebral and Cardiovascular Center Hospital

    Osaka, 5658565

  • Osaka University Hospital

    Osaka, 6560871

  • Tohoku University Hospital

    Sendai, Miyagi, 9808574

  • Tokyo Women's Medical University

    Shinjuku-Ku, Tokyo, 1628666

  • University of Tsukuba Hospital

    Tsukuba, 3058576

Other trials in Japan

Argentina3 sites

  • Fundacion Favaloro para la Docencia e Inv. med.

    Buenos Aires, Rio de La Plata, C1093AAS

  • Instituto Cardiovascular Buenos Aires (ICBA)

    Buenos Aires, Rio de La Plata, C1428ART

  • Instituto Argentino de Diagnostico y Tratamiento

    Caba, Buenos Aires, C1122AAL

Other trials in Argentina

Colombia2 sites

  • Fundacion Clinica Shaio

    Bogota, Antioquia, 110111

  • APEX Foundation

    Medellín, Antioquia, 1104

Other trials in Colombia

About this study

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.

Read the detailed description

Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.

Conditions
Heart Failure
Being tested
MPP, BiV/MPP
Keywords
MultiPoint Pacing, Heart Failure, Cardiac Resynchronization Therapy, SJM Quadripolar Biventricular Pacing
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPPDevice

    MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)

  • BiV/MPPDevice

    MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)

Study groups in NCT02832622
Study groupRoleWhat they receive
MPP ProgrammingThis post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group.
Receives: Device: MPP; Device: BiV/MPP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of CRT Responders as Measured by the Clinical Composite Score (CCS)

    The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion15 Jul 2019
  4. Study completion15 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832622
Sponsor's protocol ID
SJM-CIP-10149
Acronym
MPP-PMS
Status last verified
Feb 2021
First submitted
5 Jul 2016
Last updated
17 Feb 2021
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Abbott Medical Devices at 128 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, Japan, Argentina, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of CRT Responders as Measured by the Clinical Composite Score (CCS) (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
MultiPoint Pacing™ Post Market Study (NCT02832622) | AzTrials